| ## Anlagen zum Jahresbericht 1996 GESELLSCHAFT FÜR ARZNEIMITTELANWENDUNGSFORSCHUNG UND ARZNEIMITTELEPIDEMIOLOGIE (GAA) E.V. PD Dr. med. Liselotte von Ferber 1. Vorsitzende Postanschrift: Forschungsgruppe Primärmedizinische Versorgung der Universität zu Köln Herderstr. 52 50931 Köln Die europäische Gruppe für Arzneimittelforschung (drug utilization research group) hat auf ihrer konstituierenden Sitzung am 27. -29. Juni im Club Aliga, Ungarn die nachstehende Resolution verabschiedet. Die EURO DRUG wendet sich mit dieser Resolution an die Öffentlichkeit in der Erwartung, daß die nationalen Gesetzgebungen bei der Europäischen Direktive die in der Resolution formulierten Grundsätze berücksichtigen. Im Interesse der Patienten bedürfen die Arzneimittelanwendungsforschung und die Arzneimittelepidemologie ebenso des öffentlichen Schutzes wie die informationelle Selbstbestimmung der Bürger. |
| ### EURO DURG European Drug Utilization Research Group Resolution of the European Drug Utilization Research Group on Confidentiality of Personal Health Data (5 July 1996) The European Drug Utilization Research Group (EURO DURG) considering * The Directive 95/46/EC of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data * The need to conduct research to protect the public health and to ensure the efficient use of medicines in the healthcare systems of Member States * The need to access personal health data in order to conduct an appropriate spectrum of research with fully addresses the clinical, social and economic circumstances of patients urges European Union Member States to take into account the importance to the public health of drug utillzation and pharmacoepidemiology research when implementing the Directive 95/45/EC into national legislation. In particular Member States are urged to recognize that drug utilization and pharmacoepidemiology research is an activity "of substantial public interest" and to ensure that an exemption to the prohibition in paragraph 1 of Article 8 of the Directive, as provided for in paragraph 4 of article 8, is included in national implementation of the Directive. In the absence of such an exemption EURO DURG believes that public health research in the European Union will be inappropriately restricted with adverse consequences on the public health. Drug utilization research is an important branch of public research. It performs several functions, including * the monitoring of medicines safety after marketing * ensuring and improving quality in drug therapy by the doctor and pharmacist * monitoring and control of medicament costs in welfare state-financed health systems EURO DURG defines drug utilization and pharmacoepidemlology research as research on the quantitative and qualitative aspects of drug use, the determinants and the effects on patients specifically and the population in General. Drug utilization research is an interdisciplinary research area which employs the methodology of epidemiology, pharmacology, health services research, empirical social research and cultural anthropology. Drug utilization research investigates medicines usages in the population, the prescription habits of doctors, the market strategies of pharmaceutical companies and the effects of political interventions in the use of medicines. Drug utilization research relies on access to documents, paper and electronic, containing personal health data such as diagnoses and prescriptions. Primary surveys of medicines usage are comparatively expensive and time consuming. The use of documents from welfare state-financed health systems is an important and efficient source of data to be used to protect the public health. EURO DURG recognizes both the importance of protecting the privacy of personal health data and the importance of protecting and improving the public health by means of appropriate research. EURO DURG will seek, by means of Working Party on Confidentiality, to work with other European and national organisations to draw up a Code of Practice relating to the use of personal health data in health research in order to protect the privacy of individuals while supporting continuing improvements in public health arising from high quality research.

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am 26.03.97